GlaxoSmithKline Presents Avandia Data To FDA
GlaxoSmithKline's Avandia demonstrates the weight of scientific evidence available to address a question of increased risk of cardiovascular ischemic events.
This question was raised by different meta-analyses performed by GSK, the FDA and one published in the NEJM. Although a meta-analysis can help raise scientific questions for further investigation, such analyses can also have significant limitations. GSK believes a full and scientific evaluation of all the data does not confirm the safety questions originally raised.
Long-term clinical trials -- particularly those designed to test a specific outcome in patients with the disease -- are the most robust tools available to answer questions raised by meta-analyses. A 1997 published review of meta-analyses revealed 33% of the conclusions of meta-analyses are not confirmed by subsequent clinical trials.
Avandia is the most widely studied oral anti-diabetic medicine for the treatment of type 2 diabetes. The extensive data for Avandia includes:
-- 116 clinical trials in over 52,000 patients. These include:
-- Three, long-term clinical trials in more than 14,000 patients: ADOPT, DREAM, RECORD, with RECORD specifically studying cardiovascular effects
-- A study in a high cardiovascular-risk population: